ES2068800T3 - PHARMACEUTICAL PREPARATION IN THE FORM OF AN EFFERVESCENT AND / OR DECOMPOSITION TABLET, OR OF AN INSTANT GRANULATE, AS WELL AS A PROCEDURE FOR ITS MANUFACTURE. - Google Patents

PHARMACEUTICAL PREPARATION IN THE FORM OF AN EFFERVESCENT AND / OR DECOMPOSITION TABLET, OR OF AN INSTANT GRANULATE, AS WELL AS A PROCEDURE FOR ITS MANUFACTURE.

Info

Publication number
ES2068800T3
ES2068800T3 ES93902180T ES93902180T ES2068800T3 ES 2068800 T3 ES2068800 T3 ES 2068800T3 ES 93902180 T ES93902180 T ES 93902180T ES 93902180 T ES93902180 T ES 93902180T ES 2068800 T3 ES2068800 T3 ES 2068800T3
Authority
ES
Spain
Prior art keywords
active ingredient
pct
matrix
amount
effervescent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
ES93902180T
Other languages
Spanish (es)
Other versions
ES2068800T1 (en
Inventor
Gerhard Gergely
Thomas Gergely
Irmgard Gergely
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of ES2068800T1 publication Critical patent/ES2068800T1/en
Application granted granted Critical
Publication of ES2068800T3 publication Critical patent/ES2068800T3/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

PCT No. PCT/EP93/00055 Sec. 371 Date Jul. 13, 1994 Sec. 102(e) Date Jul. 13, 1994 PCT Filed Jan. 12, 1993 PCT Pub. No. WO93/13760 PCT Pub. Date Jul. 22, 1993The pharmaceutical formulation in the form of an effervescent and/or disintegrating tablet or of instant granules contains at least one active ingredient having an irritating taste and at least one matrix which delays the release of the active ingredient and is present as an intimate mixture with the active ingredient particles or covers said particles and is applied to a carrier. The formulation releases at most 65%, preferably at most 50%, of the active ingredient in aqueous solution at room temperature within about 2 min but more than 70%, preferably at least 80%, of the active ingredient within max. 20 min, preferably max. 15 min, in 0.1N HCl at 38 DEG C. The matrix preferably contains at least one fatty ester and/or one wax, preferably having a melting point between 30 DEG and 45 DEG C., in particular between 32 DEG and 35 DEG C., and/or at least one cellulose derivative and/or at least one polymethacrylate. In particular, the active ingredient is present in an amount of less than 60 mg, preferably less than 10 mg, and the matrix is present in an amount of 1 to 10, preferably 3 to 5, times the amount of active ingredient per tablet or granule dose. For the treatment of diarrhoea by means of loperamide, the matrix additionally contains a mixture which serves to compensate for the electrolyte loss in the body and an amount of alkali metal and/or alkaline earth metal salts, preferably of organic salts, and of chlorides.
ES93902180T 1992-01-13 1993-01-12 PHARMACEUTICAL PREPARATION IN THE FORM OF AN EFFERVESCENT AND / OR DECOMPOSITION TABLET, OR OF AN INSTANT GRANULATE, AS WELL AS A PROCEDURE FOR ITS MANUFACTURE. Expired - Lifetime ES2068800T3 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP92100441 1992-01-13

Publications (2)

Publication Number Publication Date
ES2068800T1 ES2068800T1 (en) 1995-05-01
ES2068800T3 true ES2068800T3 (en) 1995-12-16

Family

ID=8209237

Family Applications (1)

Application Number Title Priority Date Filing Date
ES93902180T Expired - Lifetime ES2068800T3 (en) 1992-01-13 1993-01-12 PHARMACEUTICAL PREPARATION IN THE FORM OF AN EFFERVESCENT AND / OR DECOMPOSITION TABLET, OR OF AN INSTANT GRANULATE, AS WELL AS A PROCEDURE FOR ITS MANUFACTURE.

Country Status (16)

Country Link
US (1) US5587179A (en)
EP (1) EP0620731B1 (en)
JP (1) JPH07506336A (en)
AT (1) ATE128028T1 (en)
AU (1) AU668375B2 (en)
CA (1) CA2127352C (en)
CZ (1) CZ283351B6 (en)
DE (1) DE59300632D1 (en)
DK (1) DK0620731T3 (en)
ES (1) ES2068800T3 (en)
FI (1) FI110353B (en)
GR (2) GR950300005T1 (en)
MX (1) MX9300110A (en)
PL (1) PL173676B1 (en)
WO (1) WO1993013760A1 (en)
ZA (1) ZA93215B (en)

Families Citing this family (41)

* Cited by examiner, † Cited by third party
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US5395627A (en) * 1992-09-04 1995-03-07 Akzo N.V. Pharmaceutical granulate
DE4403943A1 (en) * 1994-02-08 1995-08-10 Hexal Pharma Gmbh Oral preparation of the preparation with diclofenac sodium
TW466119B (en) * 1994-02-28 2001-12-01 Janssen Pharmaceutica Nv Film coated tablet of paracetamol and domperidone
GB9421836D0 (en) * 1994-10-28 1994-12-14 Scherer Corp R P Process for preparing solid pharmaceutical dosage forms of hydrophobic substances
US5837287A (en) * 1994-10-28 1998-11-17 R P Scherer Corporation Process for preparing solid pharmaceutical dosage forms
US5807577A (en) * 1995-11-22 1998-09-15 Lab Pharmaceutical Research International Inc. Fast-melt tablet and method of making same
US6974595B1 (en) * 1996-05-17 2005-12-13 Proethic Pharmaceuticals, Inc. Pharmaceutical compositions based on Diclofenae
GB9710767D0 (en) * 1996-06-26 1997-07-23 On Ninh Analgesic and anti-inflamatory compositions comprising domperidone and methods of using same
BE1011045A3 (en) * 1997-03-14 1999-04-06 Ucb Sa Pharmaceutical composition for controlled release of active substances.
US5843477A (en) * 1997-09-30 1998-12-01 Bayer Corporation Lubricants for use in tabletting
US5904937A (en) * 1997-10-03 1999-05-18 Fmc Corporation Taste masked pharmaceutical compositions
DE19814256A1 (en) * 1998-03-31 1999-10-07 Asta Medica Ag Solid, fast-breaking cetirizine formulations
DE19814257A1 (en) * 1998-03-31 1999-10-07 Asta Medica Ag effervescent formulations
DE19822036A1 (en) * 1998-05-15 1999-11-18 Bayer Ag Effervescent pharmaceutical composition with improved stability
GB9816899D0 (en) 1998-08-05 1998-09-30 Boots Co Plc Therapeutic agents
US7001612B2 (en) 1998-08-26 2006-02-21 All Sun Hsf Company Limited Composition for the relief of heat stress
US6235322B1 (en) * 1999-03-09 2001-05-22 Mintech, Inc. Highly soluble and stable mineral supplements containing calcium and magnesium
US6284270B1 (en) * 1999-08-04 2001-09-04 Drugtech Corporation Means for creating a mass having structural integrity
WO2001010405A1 (en) * 1999-08-04 2001-02-15 Ranbaxy Laboratories Limited Hydrodynamically balanced oral drug delivery system
EP1941868A3 (en) * 2000-02-28 2011-06-29 PharmaKodex Limited Improvements in or relating to the delivery of oral drugs
WO2001091730A1 (en) 2000-05-31 2001-12-06 Drugtech Corporation Mineral supplement
GB0222612D0 (en) * 2002-09-30 2002-11-06 Univ Gent Controlled delivery system for bioactive substances
KR20050083750A (en) * 2002-10-11 2005-08-26 디포메드 디벨롭먼트 리미티드 Gastr0-retentive levodopa delivery form
JP4601271B2 (en) * 2003-08-01 2010-12-22 大洋薬品工業株式会社 COMPRESSION MOLDING AND METHOD FOR PRODUCING THE SAME
WO2005021056A1 (en) * 2003-08-21 2005-03-10 Cns, Inc. Effervescent delivery system
US8216610B2 (en) * 2004-05-28 2012-07-10 Imaginot Pty Ltd. Oral paracetamol formulations
JO3352B1 (en) * 2005-06-17 2019-03-13 Apr Applied Pharma Res Sa Diclofenac formulations and methods of use
US7811604B1 (en) 2005-11-14 2010-10-12 Barr Laboratories, Inc. Non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising clozapine and methods of making and using the same
EP3449928A1 (en) 2005-11-28 2019-03-06 Imaginot Pty Ltd. Oral therapeutic compound delivery system
EP1902708A1 (en) * 2006-09-25 2008-03-26 Losan Pharma GmbH Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation
CN101084881B (en) * 2007-06-23 2012-08-29 淮北辉克药业有限公司 Targeted quick-releasing effervescence preparation and preparation method thereof
AU2008318851B2 (en) 2007-10-31 2014-04-17 Mcneil-Ppc, Inc. Orally disintegrated dosage form
US20110070301A1 (en) 2009-09-24 2011-03-24 Luber Joseph R Orally transformable tablets
US20110318411A1 (en) 2010-06-24 2011-12-29 Luber Joseph R Multi-layered orally disintegrating tablet and the manufacture thereof
US8313768B2 (en) 2009-09-24 2012-11-20 Mcneil-Ppc, Inc. Manufacture of tablet having immediate release region and sustained release region
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
PT2953617T (en) 2013-02-06 2020-01-14 Hermes Arzneimittel Gmbh Pharmaceutical compositions incorporating low-dose drugs
EP3091966B1 (en) 2014-01-10 2019-07-31 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
EP3157506B1 (en) 2014-06-20 2020-08-26 Hermes Arzneimittel GmbH Taste-masked oral pharmaceutical composition
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4289751A (en) * 1979-06-29 1981-09-15 Merck & Co., Inc. Effervescent enteric-coated formulation of soluble form of erythromycin and therapeutic use thereof
US4704284A (en) * 1982-08-12 1987-11-03 Pfizer Inc. Long-acting matrix tablet formulations
US4539198A (en) * 1983-07-07 1985-09-03 Rowell Laboratories, Inc. Solid pharmaceutical formulations for slow, zero order release via controlled surface erosion: expanded range
HU198844B (en) * 1984-06-14 1989-12-28 Sandoz Ag Process for producing new galenic pharmaceutical composition ensuring retarded release of active ingredient
DE3440288A1 (en) * 1984-11-05 1986-05-07 Gergely, Gerhard, Dr.-Ing., Wien PHARMACEUTICAL PREPARATION WITH A CONTENT OF AT LEAST ONE Mucous-irritating SUBSTANCE OR THE LIKE, PARTICULARLY PROFESSIONALS, AND METHOD FOR THE PRODUCTION THEREOF
DE3524003A1 (en) * 1985-07-04 1987-01-08 Heumann Ludwig & Co Gmbh MEDICINE GRANULES WITH DELAYED ACTIVE SUBSTANCE RELEASE AND METHOD FOR THE PRODUCTION THEREOF
EP0272265B1 (en) * 1985-09-25 1991-05-22 Gergely, Gerhard, Dr. Desintegration tablet and process for its manufacture
US4753800A (en) * 1985-10-04 1988-06-28 Warner-Lambert Company Medicament adsorbates and their preparation
NZ231281A (en) * 1988-11-08 1991-01-29 Takeda Chemical Industries Ltd Sustained release pharmaceutical preparations comprising the active agent dispersed in a solid matrix of a fatty acid ester of a polyglycerol
GB8908361D0 (en) * 1989-04-13 1989-06-01 Beecham Group Plc Composition

Also Published As

Publication number Publication date
CA2127352C (en) 2005-05-31
DK0620731T3 (en) 1996-04-09
AU668375B2 (en) 1996-05-02
WO1993013760A1 (en) 1993-07-22
AU3349293A (en) 1993-08-03
MX9300110A (en) 1994-07-29
DE59300632D1 (en) 1995-10-26
FI943315A (en) 1994-07-12
ZA93215B (en) 1993-08-19
FI110353B (en) 2002-12-31
GR3017806T3 (en) 1996-01-31
PL173676B1 (en) 1998-04-30
CZ283351B6 (en) 1998-03-18
CA2127352A1 (en) 1993-07-22
CZ160594A3 (en) 1994-12-15
FI943315A0 (en) 1994-07-12
ES2068800T1 (en) 1995-05-01
ATE128028T1 (en) 1995-10-15
US5587179A (en) 1996-12-24
EP0620731A1 (en) 1994-10-26
JPH07506336A (en) 1995-07-13
EP0620731B1 (en) 1995-09-20
GR950300005T1 (en) 1995-02-28

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